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Study Assessing QBS72S For Treating Brain Metastases
Recruiting
I'm InterestedTrial ID: NCT05305365
Purpose
This study is to evaluate the efficacy and safety of QBS72S in participants with advanced,
relapsed, metastatic breast cancer with CNS involvement.
Official Title
Phase IIa Study Assessing QBS72S For Treating Brain Metastases
Stanford Investigator(s)
Melanie Hayden Gephart
Professor of Neurosurgery and, by courtesy, of Neurology
Michael Iv
Clinical Professor, Radiology
Gordon Li, MD
Professor of Neurosurgery and, by courtesy, of Neurology and of Otolaryngology - Head & Neck Surgery (OHNS)
Reena Thomas, MD PhD
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery
Steven D. Chang, MD
Robert C. and Jeannette Powell Neurosciences Professor and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Neurology
Seema Nagpal, MD
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery
Michael Lim, M.D.
Professor of Neurosurgery and, by courtesy, of Radiation Oncology (Radiation Therapy), of Medicine (Oncology), of Otolaryngology - Head & Neck Surgery (OHNS) and of Neurology
Eligibility
Inclusion Criteria:
1. The participant must be 18 years or older
2. The participant must have a Karnofsky Performance Status (KPS) of 60 or above.
3. One of the following:
1. Cohorts 1 and 2: The participant must have a histologically-confirmed breast
cancer primary tumor, either confirmed via primary specimen or via metastasis
site, having developed brain metastases (parenchymal or LMD) after a prior
cytotoxic chemotherapy regimen.
2. Cohort 3: The participant must have a histologically cancerous primary tumor,
either confirmed via primary specimen or via metastasis site, having developed
brain metastases (parenchymal or LMD) after a prior cytotoxic chemotherapy
regimen. There is no restriction on prior cycles of systemic therapy for any
primary cancer type. Breast cancer is not excluded from Cohort 3.
4. One of the following:
1. Cohort 1: A participant with breast cancer brain parenchymal tumors must have at
least one nonirradiated tumor ≥ 3 mm2 that can be seen on 2 or more separate
acquired brain MRI sequences.
2. Cohort 2: A participant with breast cancer primary and
LMD must receive either:
i. a brain MRI with contrast that supports the presence of LMD, or ii. a CSF cytology
test that is either positive for or suspicious for malignancy. The presence of
parenchymal brain metastases does not exclude these participants from Cohort 2.
a. Cohort 3: A participant with LMD from any primary cancer site must receive either:
i. a brain MRI with contrast that supports the presence of LMD, or ii. a CSF cytology
test that is either positive for or suspicious for malignancy. The presence of
parenchymal brain metastases does not exclude these participants from Cohort 3.
5. For corticosteroids and anticonvulsants, the participant must either: c. not be taking
any, or d. be taking stable or decreasing doses for ≥5 days prior to obtaining the
screening Gd-MRI of the brain. The maximum allowable dose of corticosteroids is 8mg of
dexamethasone per day, or the equivalent of another medication as assessed by a
Neuro-Oncologist. Escalation of corticosteroids is not allowed ≤14 days prior to C1D1.
6. The participant must have completed washout from prior therapy before C1D1, as
applicable: e. ≥7 days for Ommaya placement (Cohorts 2+3) f. ≥14 days for small
molecules and non-cytotoxic systemic drugs e.g., PARP inhibitors g. ≥21 days for
checkpoint inhibitors and monoclonal antibodies, e.g., atezolizumab, pembrolizumab,
and bevacizumab, and cytotoxic chemotherapy h. ≥28 days for investigational drugs,
radiotherapy, and major surgery. Minor procedures such as tumor biopsy are allowed
with written approval from the PI i. ≥1 dosing cycle for other interventions All
significant toxicities from previous anticancer therapy must have stabilized to a new
baseline or have resolved. Participation in long term follow up in another clinical
trial is allowed if no procedures will be performed which may interfere with the
interpretation of study results.
7. The participant must have adequate bone marrow function, including: j. ANC ≥ 1,500/mm3
or ≥ 1.5 x 109/L k. Platelets ≥ 100,000/ mm3 or ≥ 100 x 109/L l. Hemoglobin ≥ 9 g/dL
8. The participant must have adequate renal function, including serum creatinine ≤ 1.5 x
ULN or estimated creatinine clearance ≥ 50 mL/min. In equivocal cases, a 24-hour urine
collection test can be used to estimate the creatinine clearance more accurately.
9. The participant must have adequate liver function, including: m. Total serum bilirubin
≤ 1.5 x ULN unless the participant has documented Gilbert syndrome who must have a
total bilirubin < 3.0 mg/dl n. Aspartate and Alanine aminotransferase (AST and ALT) ≤
2.5 x ULN; ≤ 5.0 x ULN if there is liver involvement by the tumor
10. Any participant physiologically capable of becoming pregnant or getting a partner
pregnant must agree to use highly effective contraception during study treatment and
for 7 months after study discontinuation.
11. Participants or their designated advocates must be willing to and capable of providing
informed consent and willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures
Exclusion Criteria
1. Participants with any other current, active malignancy unrelated to their primary
cancer diagnosis, except for adequately treated basal cell or squamous cell skin
cancer or carcinoma in situ.
2. Participants with intolerance to or who have had a severe (Grade 3) allergic or
anaphylactic reaction to any of the substances included in the investigational
product: sulfobutylether-β-cyclodextrin, melphalan, bendamustine, chlorambucil or any
nitrogen mustard chemotherapeutics.
3. Participants who currently use or have an anticipated need for a contraindicated
medication including live vaccines, natalizumab, nivolumab, ocrelizumab, palifermin,
pimecrolimus, tacrolimus, tofacitinib, and EIAEDs, including phenytoin, phenobarbital,
carbamazepine, fosphenytoin, primidone, and oxcarbazepine. The washout period for any
live vaccine is 30 days prior to enrollment. There is no restriction for seasonal flu
vaccines that do not contain live virus, nor any approved COVID vaccine.
4. Participants who are pregnant or breastfeeding.
5. Participants who have active medical or psychiatric conditions which, in the opinion
of the Principal Investigator or a Sub-Investigator, would compromise or interfere
with their ability to participate in the study.
Intervention(s):
drug: QBS72S
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Monica Granucci
650-388-8906